Prospective, Multicenter Study of the Efficacy and Tolerance of Tacrolimus on Refractory Nephrotic Syndrome (RNS)

This study has been completed.
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00615667
First received: February 1, 2008
Last updated: March 7, 2011
Last verified: October 2008
  Purpose

Exploring the efficacy and safety of Tacrolimus on refractory nephrotic syndrome ; Acquiring the experience of Tacrolimus on the treatment of refractory nephrotic syndrome in Chinese patients.


Condition Intervention Phase
Kidney Diseases
Nephrotic Syndrome
Tacrolimus
Drug: tacrolimus (FK506)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Remission rate [ Time Frame: 2006-2008 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Renal function, proteinuria, relapse [ Time Frame: 2006-2008 ] [ Designated as safety issue: Yes ]

Enrollment: 61
Study Start Date: June 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
tacrolimus(fk506) treatment
Drug: tacrolimus (FK506)
Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;

  Eligibility

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects of either sex, 14-65 years of age;
  2. Diagnosis of Nephrotic syndrome with hypoalbuminemia (<3.0g/dl) and heavy proteinuria (> 3.5g/24hr);
  3. Provision of written informed consent by subject or guardian;
  4. Refractory nephrotic syndrome:

Steroid resistant: Persistence of proteinuria despite prednisone therapy 1mg/kg/d for 16 weeks; Steroid dependent: NS recurs when steroid dosage decease.Twice within 6 months, and 3 times within 1 year.

Exclusion Criteria:

  1. Inability or unwillingness to provide written informed consent ;
  2. Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide, azathioprine, corticosteroids;
  3. Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;
  4. Pregnancy, nursing or use of a non-reliable method of contraception;
  5. Continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks;
  6. Previous kidney transplant or planted transplant;
  7. Scr > 4mg/dl (353umol/L);
  8. Active hepatitis, with liver dysfunction;
  9. Diagnosed DM;
  10. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615667

Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Xue qing Yu, MD Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Principal Investigator: Ping Fu, MD Department of Nephrology, West China Hospital of Sichuan University
Principal Investigator: Yun Hua Liao, MD Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University
Principal Investigator: Jin li Zhang, MD Department of nephrology, People's Hospital of Yunnan Province
Principal Investigator: Jian Chen, MD Department of Nephrology, Fuzhou Military General Hospital
Principal Investigator: Tan Qi Lou, MD Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen University
Principal Investigator: Yao zhong Kong, MD Department of Nephrology, 1st People's Hospital of Foshan
Principal Investigator: Jun zhou Fu, MD Department of Nephrology,1st People's Hospital of Guangzhou
Principal Investigator: Wei Shi, MD Department of Nephrology, People's Hospital Guangdong Provincial
Principal Investigator: Zheng rong Liu, MD Department of Nephrology, Nanfang Hospital of Southern Medical University
  More Information

No publications provided

Responsible Party: Xueqing Yu, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00615667     History of Changes
Other Study ID Numbers: SYSU-PRGNS-001
Study First Received: February 1, 2008
Last Updated: March 7, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Refractory Nephrotic syndrome
Tacrolimus

Additional relevant MeSH terms:
Kidney Diseases
Nephrotic Syndrome
Urologic Diseases
Nephrosis
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014